A Crossover Study to Compare RAYOS to IR Prednisone to Improve Fatigue and Morning Symptoms for SLE
RIFLE
A Randomized, Double-Blind, Active Comparator-Controlled, Crossover Study to Assess the Capacity of RAYOS® Compared to Immediate-Release Prednisone to Improve Fatigue and Control Morning Symptoms in Subjects With Systemic Lupus Erythematosus
1 other identifier
interventional
62
1 country
21
Brief Summary
To compare the effect of RAYOS® versus immediate-release (IR) prednisone on fatigue as measured by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Sep 2017
Typical duration for phase_4
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2017
CompletedFirst Posted
Study publicly available on registry
April 4, 2017
CompletedStudy Start
First participant enrolled
September 12, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2020
CompletedJuly 8, 2020
July 1, 2020
1.7 years
March 21, 2017
July 7, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Fatigue
Fatigue as measured in FACIT-F by patient
3 months
Study Arms (2)
RAYOS®
EXPERIMENTALIR prednisone
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Provide written informed consent agreeing to all study procedures, before any study-specific procedures are done.
- Males or non-pregnant females, aged 18 years or older
- Diagnosis of SLE by either the American College of Rheumatology (ACR) or Systemic Lupus International Collaborating Clinics Classification (SLICC) criteria
- Fatigue measured by FACIT-F ≤30.
- On a stable regimen of IR prednisone (5 to 15 mg/day) for a period of at least 30 days prior to Screening, expected to remain stable for the next 6 months.
- On a stable SLE treatment regimen for a period of at least 30 days prior to Screening, and expected to remain stable for the next 6 months. Any of the following medications are permitted if stable for at least 30 days prior to Screening and expected to remain stable for the next 6 months:
- Hydroxychloroquine or equivalent anti-malarial
- Other immunosuppressive or immunomodulatory agents including methotrexate, azathioprine, leflunomide, mycophenolate (including mycophenolate sodium or mycophenylate mofetil at no more than 2 grams/day), belimumab, cyclophosphamide, calcineurin inhibitors (e.g. tacrolimus, cyclosporine)
- Entry of daily ePRO data on 11 of 14 days during the baseline period, and completion of at least 6 out of the 8 weekly ePRO questionnaires during the baseline period
- Willing and able to perform and comply with all study procedures, including taking pills daily as prescribed, completing the ePROs on the smart phone, wearing the smart watch day and night, bringing the smartphone on all activities away from home (e.g., walks, errands, visiting, shopping, traveling), keeping the smartphone and smartwatch charged daily, carefully using the smartphone and smartwatch as clinical tools and keeping them secure from others, and attending monthly clinic visits as scheduled
- Females of childbearing potential must be currently using a highly effective method of contraception that may include, but is not limited to, abstinence, sex only with persons of the same sex, monogamous relationship with vasectomized partner, hysterectomy, bilateral tubal ligation, licensed hormonal methods, intrauterine device, or use of a spermicide combined with a barrier method (e.g., condom, diaphragm) for 30 days before and 90 days after receiving the study drug
You may not qualify if:
- Previously taken any of the following medications:
- RAYOS®
- Rituximab within 6 months prior to Screening
- Any investigational therapy within 3 months or 5 half-lives of the agent prior to Screening
- History of noncompliance with taking pills as prescribed.
- Rapidly progressive neurologic disease
- Rapidly progressive renal disease (defined by proteinuria \>6 g/24 hours or equivalent using spot urine protein to creatinine ratio, or serum creatinine \>2.5 mg/dL)
- Diagnosis of fibromyalgia
- Any of the following clinical laboratory abnormalities:
- Hemoglobin \<8.0 mg/dL
- Platelet count \<50,000/mm3
- White blood count (WBC) ≤ 2000/mm3; may be 1999-1000/mm3 if stable and related to SLE
- Absolute neutrophil count (ANC) ≤1000/mm3; may be 500-999/mm3 if stable and related to SLE
- Aspartate transaminase (AST) or alanine transaminase (ALT) ≥3× upper limit of normal (ULN) unless related to SLE
- Calculated creatinine clearance ≤25 mL/min per 1.73 m2 (by Cockcroft-Gault equation)
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
The Regents of the University of California, Los Angeles
Los Angeles, California, 90095, United States
University of California-Irvine
Orange, California, 92868, United States
Stanford University
Palo Alto, California, 94304, United States
The Regents of the University of California, San Diego
San Diego, California, 92037, United States
University of California-San Francisco
San Francisco, California, 94143, United States
Yale School of Medicine
New Haven, Connecticut, 06519, United States
University of Florida College of Medicine
Gainesville, Florida, 32610, United States
Miller School of Medicine at the University of Miami
Miami, Florida, 33136, United States
Northwestern University
Chicago, Illinois, 60611, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Maryland School of Medicine
Baltimore, Maryland, 21201, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
UMASS Memorial Medical Center-Memorial Campus
Worcester, Massachusetts, 01605, United States
The Hospital for Special Surgery
New York, New York, 10021, United States
Columbia University Medical Center
New York, New York, 10032, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
The MetroHealth System
Cleveland, Ohio, 44109, United States
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, 73104, United States
Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Temple University
Philadelphia, Pennsylvania, 19140, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2017
First Posted
April 4, 2017
Study Start
September 12, 2017
Primary Completion
May 28, 2019
Study Completion
June 15, 2020
Last Updated
July 8, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share